Anchor Systems and Methods

ABSTRACT

Some embodiments of a medical device anchor system include an anchor device that receives a medical instrument (such as a catheter or the like) and secures the instrument in place relative to a skin penetration point. In some circumstances, the anchor device may allow the anchor device to be used after medical instrument is already in place without the need for a second penetration point for the anchor device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. application Ser. No. 14/711,053 filed onMay 13, 2015, which is a continuation of U.S. application Ser. No.14/070,143 filed on Nov. 1, 2013 by Rosenberg et al., which is acontinuation of U.S. application Ser. No. 13/738,005 filed on Jan. 10,2013 by Rosenberg et al., which is a continuation of U.S. applicationSer. No. 13/228,079 filed on Sep. 8, 2011 by Rosenberg et al., which isa continuation of U.S. application Ser. No. 12/174,306 filed on Jul. 16,2008 by Rosenberg et al. The contents of these prior applications arefully incorporated herein by reference.

TECHNICAL FIELD

This document relates to an anchor device, such as a device for use insecuring the position of a catheter or other medical instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is secured to the patient. In conventionalpractice, the catheter is commonly secured to the patient using anadhesive tape on the skin or by suturing a catheter hub to the patient'sskin.

SUMMARY

Some embodiments of a medical device anchor system include an anchordevice that receives a medical instrument (such as a catheter or thelike) and secures the instrument in place relative to a skin penetrationpoint. In some circumstances, the anchor device can be actuated so thatsubcutaneous anchors are inserted through the skin penetration pointthat is already occupied by the medical instrument. Such a configurationmay allow the anchor device to be used after medical instrument isalready in place without the need for a second penetration point for theanchor device. In particular embodiments, the anchor device may have amulti-piece design that can simplify removal of the device and reducetrauma to surrounding tissue near the penetration point. For example,the anchor device can be separated into at least two portions prior toremoval from the skin penetration point. In these circumstances, theseparable portions may include a subcutaneous anchor, and each anchorcan be removed from the skin penetration point independently of theother in a manner that reduces the likelihood of damage to the tissuesurrounding the skin penetration point.

Particular embodiments may include an anchor system for securing amedical instrument. The system may include a retainer body to couple toa catheter. The system may also include a plurality of flexible anchorsreleasably coupled to the retainer body. Each anchor may comprise aflexible tine that is deployable in a subcutaneous region to secure theretainer body relative to a penetration point. The system may furtherinclude an actuator that, when activated, moves the anchors from anon-deployed position to a deployed position in which the anchorsflexible anchors extend distally from the retainer body and into thesubcutaneous region.

In some embodiments, an anchor system for securing a medical instrumentmay include a retainer body to couple with a medical instrument. Thesystem may also include one or more anchors that are deployable througha penetration point and into subcutaneous region so as to secure theretainer body relative to the penetration point. The system may furtherinclude a separable delivery device including an actuator that, whenactivated, moves the first and second anchors from a non-deployedposition to a deployed position in which the anchors flexible anchorsextend distally from the retainer body and into the subcutaneous region.The system may also include a release member that releasably couples thefirst and second anchors to the retainer body. The release member may beadjustable from a first position to a second position in which the firstand second anchors are decoupled from the retainer body.

In other embodiments, a method of anchoring a catheter may includeadvancing a catheter through a skin penetration point. The method mayalso include directing an anchor device toward the skin penetrationpoint that is occupied by a portion of the catheter. The anchor devicemay comprise a retainer body to releasably couple to an external portionof the catheter arranged outside of a biological body, and at least onedeployable anchor that is longitudinally adjustable relative to theretainer body from a non-deployed position to a deployed position inwhich the at least one anchor extends distally from the retainer body.The method may further include deploying the anchor through thepenetration point that is occupied by the catheter so that at least aportion of the anchor is deployed in a subcutaneous region proximate thepenetration point.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor system can retain amedical instrument in a desired position relative to a skin penetrationpoint without necessarily requiring sutures or skin adhesives. Second,in some embodiments, an anchor device can include a retention portionthat readily mates with a medical instrument (such as a catheter) and atleast one anchor extending distally from the retention portion to engagethe skin penetration point as the medical instrument. Third, the anchordevice can include one or more anchors configured to deploy in asubcutaneous region under the skin proximate to the skin penetrationpoint of the medical instrument. In such circumstances, the anchors maybe inserted through the skin penetration point in a manner that reducesthe likelihood of trauma to the surround skin tissue. Fourth, in someembodiments, the anchor device may include multiple components that areseparable from one another before the anchor device is removed from theskin. For example, the anchor device may include a first portion and asecond portion that are coupled together (as the fully assembled anchordevice) during insertion into the skin penetration point, but the firstand second portions can be readily separated from one another tofacilitate removal from the skin. Accordingly, the anchors andassociated tines can collectively penetrate into the subcutaneous regionas part of the assembled device, and may be separately and individuallywithdrawn from the penetration point during the removal process. Such aconfiguration can permit the first and second portions to be maneuveredin a manner that reduces the likelihood of causing damage to the skinduring removal of the anchors. Fifth, some embodiments of the anchordevice may include a delivery device that facilitates delivery of theanchors toward the skin penetration point. For example, the deliverydevice may be configured as a disposable, hand-held actuator thatprovides for convenient grasping by a user. Moreover, the deliverydevice can be actuated so as to deploy the anchors into the subcutaneousregion before the delivery device is removed from the anchor device.

The details of one or more embodiments are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a system with a portion of an anchordevice located in a subcutaneous region, in accordance with someembodiments.

FIG. 2 is an exploded view of the anchor device of FIG. 1.

FIG. 3 is a perspective view of the anchor device of FIG. 1 in anon-deployed configuration.

FIG. 4 is a perspective view of the anchor device of FIG. 1 in adeployed configuration.

FIG. 5 is a perspective view of the anchor device of FIG. 1 in an openedposition.

FIGS. 6A-I are perspective views of an exemplary implementation of theanchor device of FIG. 1.

FIG. 7 is an exploded view of an anchor device, in accordance withfurther embodiments.

FIG. 8 is a perspective view of the anchor device of FIG. 7.

FIG. 9 is another perspective view of the anchor device of FIG. 7.

FIGS. 10A-G are perspective views of an exemplary implementation of theanchor device of FIG. 7.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a medical device anchor system10 include an anchor device 100 that releasably retains a medicalinstrument 20 (e.g., depicted as a catheter in this embodiment) in anoperative position relative to a skin penetration point 32. The anchordevice 100 may include a retainer body 110 that receives the medicalinstrument 20 and can releasably engage with an outer surface of themedical instrument 20. The medical instrument 20 extends from theretainer body 110 and through the penetration point 32 in the patient'sskin 30 (e.g., through an incision or the like), while the retainer body110 remains outside of the skin 30. As described in more detail below,the anchor device 100 can secure the catheter 20 in the operativeposition relative to the penetration point 32 without necessarilyrequiring sutures or adhesive tapes bonded to the skin. In thisembodiment, the anchor device 100 can include an actuator 130 that canbe activated to shift one or more anchors 120 a-b distally from theretainer body 110. As such, the anchors 120 a-b can be directed topenetrate through the same skin opening as the medical instrument 20.The anchors 120 a-b can include tines 129 a-b that, after insertion, aredeployed in a subcutaneous region 34 (e.g., a region under the skin 30that can comprise a fatty tissue layer) so as to secure the position ofthe anchor device 100—and the medical instrument 20 retainedtherein—relative to the skin penetration point 32.

In some embodiments, the medical instrument 20 can include a catheterthat can be inserted through the penetration point 32 of the skin 30 aspart of a medical procedure. For example, in the embodiment depicted inFIG. 1, a central venous catheter 20 can be inserted into a percutaneousopening surgically formed in the skin (e.g., penetration point 32), tothe underside of the skin 30, and into a vein 40 to provide vascularaccess for delivering medications or minimally invasive devices into apatient. As described in greater detail below, after placement of thecatheter 20, the anchor device 100 (arranged in the open configurationas shown in FIG. 3) can be guided along the catheter 20 and toward thepenetration point 32. When a mouth 113 (FIG. 2) of the retainer body 110reaches the penetration point 32, the user can adjust the actuator 130so as to extend the anchors 120 a-b distally from the retainer body 110.As such, the tips 122 a and 122 b (FIG. 2) of the anchors 120 a and 120b are urged into the skin 30 through the penetration point 32. When theanchors 120 a-b are inserted through the penetration point 32, the tines129 a and 129 b can pass through the penetration point with reducedtrauma to the surrounding skin tissue. As the anchors 120 a and 120 bare collectively advanced through the penetration point 32, the tines129 a and 129 b are moved beneath the dermal layers 36 (e.g., thedermis, the epidermis, etc.) of the skin 30. When the tines 129 a and129 b reach the subcutaneous region 34, the tines 129 a and 129 b candeploy in the subcutaneous region 34. As shown in FIG. 1, the anchors120 a and 120 b may be designed such that the tines 129 a and 129 binclude a curvature that abuts against the underside of the dermallayers 36 in a manner that reduces the likelihood of the tines 129 a and129 b puncturing through the underside of the dermal layers 36. When thetines 129 a and 129 b of the anchors 120 a and 120 b are deployed in thesubcutaneous region 34, the anchor device 100 can be secured to thepatient without the retainer body 110 penetrating though the skin 30 ofthe patient and without necessarily requiring sutures or adhesive tapesto bond the retainer body 110 to the skin 30.

Referring now to FIGS. 1 and 2, in some embodiments, the actuator 130can be movably coupled to the retainer body 110 so as to shift the tines129 a-b from a non-deployed position to a deployed position. Actuator130 includes anchors 120 a-b that forwardly extend from respective firstand second actuator body portions 131 a and 131 b. In some embodiments,the anchors 120 a-b include over-molded portions (not shown in FIG. 1 or2) that extend into respective actuator body portions 131 a-b to givethe anchors 120 a-b rigidity and support.

In one embodiment, the actuator 130 mates with a channel 111 at leastpartially defined by the retainer body 110 such that the actuator 130can slide longitudinally forward and rearward relative to the channel111. The actuator 130 can include a tongue portion 133 on opposing sidesof the actuator 130 that slidably couples the actuator 130 with a grooveportion 134 on the retainer body 110. Such a mating configuration guidesthe sliding motion of the actuator 130 relative to the retainer body110.

In some embodiments, the actuator 130 includes a stop member 136 (FIG.2) that can limits the travel of the anchors 120 a-b in the longitudinaldirection. As shown in FIG. 2, the stop member 136 can include wings 137a-b that engage the retainer body 110 to prevent the actuator 130 fromadvancing further in the longitudinal direction relative to the retainerbody 110 during deployment of the anchors 120 a-b. In some embodiments,the stop member 136 positively locks into a fixed position when itengages the retainer body 110 so as to prevent the actuator 130 fromprematurely “backing out” of the retainer body 110. In some embodiments,the stop member 136 is adjustable so as to permit the retainer body 110to decouple from the anchors 120 a-b (e.g., during removal of thecatheter 20), as described in more detail below.

The actuator 130 can include two or more components (e.g., body portions131 a-b) that are releasably secured together by the retainer body 110.Such a configuration permits the anchors 120 a-b to be coupled togetherduring insertion into the skin penetration point 32, but then theanchors 120 a-b can be readily separated from one another (after theretainer body 110 disengages the actuator 130) to facilitate individualremoval from the skin. For example, when the tines 129 a-b are beingdeployed through the skin penetration point 32, the actuator bodyportions 131 a-b are coupled in a side-by-side abutting relationshipsuch that the anchors 120 a-b are retained substantially adjacent toeach other. Thereafter, the actuator 130 can separate from the retainerbody 110 (described below in connection with FIGS. 6G-H) so that thebody portions 131 a-b are movable relative to one anther. As such, theactuator 130 can be separated into two components—the first body portion131 a (from which the first anchor 120 a extends) and the second bodyportion 131 b) (from which the second anchor 120 b extends).

Still referring to FIGS. 1 and 2, the retainer body 110 can include aninstrument retention member 140 used to secure the catheter 20 (or othermedical instrument) relative to the skin penetration point 32. Forexample, after the catheter 20 is delivered into the targeted vein 40(or other bodily lumen) and after the anchors 120 a and 120 b aredeployed in the subcutaneous region 34, the retention member 140 can beapplied to the catheter 20 to secure its position relative to theretainer body 110 (as described below). In one embodiment, the retentionmember 140 can be releasably coupled to the catheter 20 through africtional engagement (e.g., compression along an outer wall of thecatheter 20), although other coupling mechanisms can be implemented.Because the retention member 140 may be coupled with the retainer body110 (which is secured to the penetration point 32 by the deployedanchors 120 a-b), the anchor device 100 can be used to temporarilysecure the catheter 20 relative to the penetration point 32.

In this embodiment depicted in FIGS. 1 and 2, the retention member 140may be removably attached to the retainer body 110 using one or moreapertures 141 and 149 that mate with corresponding extensions 151 and159. The retention member 140 may comprise a flexible material, such assilicone or another biocompatible polymer material. For example, atleast a flexible wall portion 142 may comprise silicone or anotherbiocompatible polymer material so that a second region 143 b canflexibly adjust relative to a first region 143 a. In such circumstances,the apertures 141 and 149 can be forced over the correspondingextensions 151 and 159, and thereafter (if desired) one aperture 149 canbe lifted from the retainer body 110 while the another aperture 141remains secured to the retainer body 110, as described below.

The retention portion 140 can secure the catheter 20 relative to theskin penetration point 32 throughout the medical procedure in which thecatheter 20 is employed. For example, after the catheter 20 is deliveredinto the targeted vein 40 (or other bodily lumen) and after the anchors129 a-b are deployed in the subcutaneous region (proximate to the skinpenetration point), the retention member 140 can be adjusted so that thecatheter 20 is frictionally engaged inside a channel 145. In particular,the retention member 140 can be transitioned from an open configuration(refer to FIG. 6B) to a closed configuration (refer to FIG. 6C) tothereby secure the catheter 20 within the channel 145 of the retentionmember 140. The channel 145 may be at least partially defined by a wallcomprising silicone or another flexible polymer that compresses against,and applies a holding force to, the outer surface of the catheter 20(without compromising the operation of the internal catheter lumen(s)).As such, in some embodiments, the anchor device 100 can be secured tocatheter 20 without the use of adhesives. It should be understood fromthe description herein that, in alternative embodiments, the anchordevice 100 may include an adhesive pad to supplement the holding forcesapplied by the retention member 140.

In use, the anchor device 10 can include features that facilitateseparation from the catheter 20 and removal from the skin in a mannerthat reduces the likelihood of trauma to the skin surrounding thepenetration point. For example, the retention member 140 can include atab 148 that can be readily grasped by a user to lift the second region143 b from the retainer body 110, thereby opening the channel 145 forremoval of the catheter 20. After the retention member 140 is shifted tothe open configuration (refer to FIG. 6D), the catheter 20 can beseparated from the channel 145 and removed from the anchor device 100(e.g., to withdraw the catheter 20 from the patient while the anchordevice 100 remains secured to the skin penetration point 32). Moreover,the anchor device 100 can include separable portions that can bedisassembled prior to removal of the anchors 120 a-b from thesubcutaneous region. For example, in this embodiment, the anchor device100 comprises an assembly of two pieces (refer to FIG. 6I) that canseparate from one another to facilitate removal of one anchor 120 aindependent of the other tine 120 b. Such a configuration permits theanchors 120 a-b to be maneuvered in a manner that reduces the likelihoodof causing damage to the skin during removal.

Referring now to FIGS. 3-4, some embodiments of the anchor device 100can be actuated so as to shift the anchors 120 a-b from a non-deployedconfiguration to a deployed configuration. When the anchors 120 a-b arearranged in the non-deployed configuration (FIG. 3), the entire anchordevice 100 may reside outside the patient's body. As the mouth 113 ofthe anchor device 100 is delivered to the skin penetration point 32, theactuator 130 can adjust within the retainer body 110 so as to direct theanchors 120 a-b through the skin penetration point 32 and into thedeployed configuration (FIG. 4). The anchors 120 a-b can includefeatures that facilitate advancement into the subcutaneous region in amanner that reduces the likelihood of damage to surrounding tissue. Forexample, in some embodiments, the anchors 120 a-b may comprise amaterial that exhibits superelasticity when used in a patient's body. Assuch, when the anchor tines 129 a-b of anchors 120 a-b are insertedthrough the skin penetration point 32, the tines 129 a-b cansuperelastically flex from an expanded position to a contracted position(e.g., in which the tines are pressed against the sides of the anchorbodies 124 a-b). While flexed toward the anchor bodies 124 a-b, thetines 129 a-b can readily penetrate through the skin penetration point32 (which may be generally smaller in width than the width occupied bythe tines 129 a-b in a fully expanded state). Such anchor insertiontechniques can reduce the damage to the patient's skin 30 duringdeployment of the anchors 120 a-b. In the embodiments in which theanchors 120 a-b can superelastically flex, at least portions of theanchors 120 a-b (including the tines 129 a-b) may be formed from alength of nitinol wire or from a sheet of nitinol material, which hasbeen processed to exhibit superelasticity below or at about a normalhuman body temperature, such as below or at about 37 degrees C. Thenitinol material may comprise, for example, Nickel Titanium (NiTi),Niobium Titanium (NbTi), and the like. Alternatively, the anchors 120a-b may comprise a metal material such as stainless steel (e.g., 304stainless, 316 stainless, custom 465 stainless, and the like), springsteel, titanium, MP35N, and other cobalt alloys, or the like. In anotheralternative, the anchors 320 a and 320 b may be formed from a resilientpolymer material. In these embodiments, the anchors 120 a-b can beformed from a material or materials that allow the tines 129 a-b to beflexed to a contracted position (e.g., as in FIG. 3) and can resilientlyreturn to an expanded position (e.g., as in FIG. 4). To further decreasethe insertion profile of the anchors 320 a-b as they are inserted intothe skin 30, the anchor bodies 324 a and 324 b can include recesses,such as the recess 326 a and the corresponding recess (not shown) in theanchor body 324 b into which at least a portion of the tines 322 a-b caninwardly flex. As such, the recesses in the anchor bodies 324 a-b can atleast partially accommodate the tines 322 a-b when they are flexed intothe contracted position, thereby further reducing the insertion profileof the anchors 320 a-b.

As shown in FIG. 3, the anchors 120 a-b are arranged in a non-deployedconfiguration and contained within the actuator channel 111 of theretainer body 110. The tines 129 a-b of the anchors 120 a-b may beretained in a stressed position by the walls of the channel 111, and thetines 129 a-b may be biased to outwardly flex upon advancing from themouth 113 of the retainer body 110. In the configuration shown in FIG.3, a rearward portion of the actuator 130 may extend from the proximalend of the retainer body 110 so that a user can apply an actuation forceto the actuator 130. As previously described, the actuation force can beapplied to the actuator 130 so that the actuator 130 is advanced in thelongitudinal direction within the channel 111 of the retainer body.

As shown in FIG. 4, the actuator 130 is adjusted relative to theretainer body 110 so that the anchors 120 a-b can exit the mouth 113 andshift toward the deployed configuration. In this embodiment, therearward portion of the actuator 130 has been advanced by the actuationforce so that the stop member 136 engages a complementary cavity of theretainer body 110. As such, the stop member 136 can limit the distalmotion of the anchors 120 a-b during deployment through the skinpenetration point 32. When the anchors 120 a-b are shifted to thedeployed configuration, the anchors 120 a-b extend distally from theretainer body 110. In these circumstances, the anchors 120 a-b can bedeployed in the subcutaneous region 34 (FIG. 1) while the remainingportions of the anchor device 100 reside outside the skin. Thus, theanchor device 100 may engage the medical instrument (e.g., catheter 20)outside the skin while the anchors 120 a-b extend distally through thesame skin penetration point 32 occupied by that medical instrument(e.g., catheter 20).

Referring now to FIGS. 4-5, the retention member 140 of the anchordevice 100 can be shifted between a closed position (FIG. 4) and an openposition (FIG. 5) so as to releasably engage the medical instrument(e.g., the catheter 20 in this particular embodiment). As previouslydescribed, the retention member 140 may, in certain embodiments, includeregions 143 a-b that can adjust relative to one another so as to revealthe channel 145 therebetween (e.g., to insert a portion of the medicalinstrument). The regions can be movable joined at an interface thatincludes, for example, one or more folds, creases, micro-hinges,perforations, or the like. The retainer body 110 can includes lockingposts 151 and 159 that serve to releasably secure the retention member140 in the closed position. For example, the retention member 140 may beremovably attached to the retainer body 110 using the apertures 141 and149 that mate with the corresponding posts 151 and 159. The retentionmember 140 may comprise silicone or another flexible material so thatthe second region 143 b can flexibly adjust relative to the first region143 a. Accordingly, the apertures 141 and 149 can be forced over thecorresponding posts 151 and 159, and thereafter the user may lift thesecond region 143 b from the retainer body 110 while the first region143 a remains secured to the retainer body 110 (refer to FIG. 5). Thisadjustment of the retention member 140 provides access to the channel145 so that the catheter 20 or other medical instrument can be arrangedtherein. When the retention member 140 is returned to the closedposition (refer to FIG. 4), the wall of the channel 145 can compressesagainst, and apply a frictional engagement to, the outer surface of thecatheter 20.

Referring now to FIGS. 6A-6I, some embodiments of the anchor device 100can be implemented to secure a medical instrument at a selected locationon a patient's body. For example, the anchor device 100 can be used incertain processes to secure the catheter 20 in a selected positionrelative to the skin penetration point 32 that is occupied by thecatheter 20. Moreover, the anchor device 100 may properly secure thecatheter 20 in this operative position without necessarily requiringsutures or adhesive tapes bonded to the skin.

As shown in FIG. 6A, a medical instrument (in this particular example, acatheter 20) has been delivered through a patient's skin 30, through thesubcutaneous layer 34, and into a targeted vein 40. After the catheter20 is advanced through the skin, the anchor device 100 can be directedalong the catheter 20 and toward the skin penetration point 32 that isoccupied by the catheter. As previously described, the skin penetrationpoint 32 can be formed, for example, by an incision in the skin 30. Inthis embodiment, the anchor device 100 is advanced along the outersurface of the catheter 20 while the retention member 140 is in the openposition. As such, a guide channel 132 (FIG. 2) defined by the actuator130 can be guided by the outer surface of the catheter 20 while theanchor device 100 is advanced toward the skin penetration point 32. Whenthe mouth 113 (FIG. 2) of the anchor device 100 is arranged proximate tothe skin penetration point 32, the user can prepare to shift the anchors120 a-b away from the non-deployed configuration.

Referring to FIG. 6B, the anchor device 100 can be secured to the skinpenetration point 32 by deploying anchors 120 a-b through the skinpenetration point 32 and into the subcutaneous layer 34. As previouslydescribed, the user can adjust the actuator 130 so as to advance theanchors 120 a-b out of the mouth 113 and through the skin penetrationpoint 32. For example, the user can deploy the anchors 120 a-b byapplying a force to the actuator 130 that causes the actuator 130 adjustin the distal direction until the stop member 136 engages the matingcavity of the retainer body 110, thus limiting further longitudinalmovement of the anchors 120 a-b. In some embodiments, the stop member136 of the actuator 130 positively engages with the retainer body 110such that the actuator 130 locks in the deployed position and therebyreduces the likelihood of the anchor device 100 prematurely releasingfrom the skin 30. In this embodiment, the catheter 20 is depicted asbeing positioned in the channel 145 of the retention member 140 (in theopen position) before the anchors 120 a-b are deployed into the skinpenetration point 32. It should be understood from the descriptionherein that, in other embodiments, the catheter 20 may be fit into thechannel 145 after the anchors 120 a-b are deployed into the subcutaneouslayer 34.

As shown in FIG. 6C, the retention member 140 can be adjusted to theclosed position so as to retain the catheter 20 in the selectedposition. Thus, after the catheter 20 is delivered into the targetedvein 40 (or other bodily lumen) and after the anchors 120 a-b aredeployed in the subcutaneous region 34, the retention member 140 canlockingly engage the catheter 20 to secure its position relative to theretainer body 110. As previously described, the retention member 140 canbe releasably coupled to the catheter 20 through a frictional engagement(e.g., compression along an outer wall of the catheter 20), whichprovides a temporarily holding force on the catheter 20 relative to thepenetration point 32. In this embodiment, the retention portion 140 cansecure the catheter 20 relative to the skin penetration point 32throughout the medical procedure in which in the catheter 20 inemployed. The configuration illustrated in FIG. 6C shows the anchordevice 100 as it may be used to secure a patient's catheter 20 over aperiod of time, for example, for hours, one to seven days, or longer. Aspreviously described, the retention member 140 can be transitioned fromthe open position (refer to FIG. 6B) to the closed position (refer toFIG. 6C) by securing the first and second regions 143 a-b to thecorresponding locking posts 151 and 159 (e.g., so that the channel 145substantially surrounds the catheter 20).

Referring now to FIGS. 6D-6I, the catheter 20 may be withdrawn from thepatient (e.g., after the procedure) while the anchors 120 a-b remain inthe subcutaneous region 34. In some embodiments, the anchors 120 a-b maybe coupled together (as part of the fully assembled anchor device 100)during insertion into the skin penetration point 32 (refer to FIG. 6B),but thereafter the anchors 120 a-b can be readily separated from oneanother to facilitate removal from the skin (refer to FIG. 6I).Accordingly, the anchors 120 a-b and associated tines 129 a-b cancollectively penetrate into the subcutaneous layer 34 as part of theassembled device 100, and may be separately and individually withdrawnfrom the penetration point 32 during the removal process.

In the embodiment depicted in FIG. 6D, when the catheter 20 is to beremoved from the skin 30, the catheter 20 may be released from theretention member 340 by lifting at least one of the regions 143 a-b fromthe locking posts 151 and 159 (illustrated by the curved arrow in FIG.6D). This adjustment of the second region 143 b relative to the lockingpost 159 effectively releases the grip on the catheter 20 and allows thecatheter 20 to be withdrawn the catheter 20 from the patient's skin 30.In some implementations, the guide channel 132 (FIG. 2), the openedchannel 145, or both may be used as a guide in removing the catheter 20to thereby reduce trauma to surrounding tissue.

As shown in FIG. 6E, after the catheter withdrawal force 27 is appliedto retract the catheter 20 from the skin 30, the anchor device 100 canbe removed. In this embodiment, the anchor device 100 can be removedfrom the patient through a disassembly procedure that allows the anchors120 a-b to decouple from the retainer body 110. After the anchors 120a-b are free from the retainer body 110, they can be individuallymaneuvered in such a way as to reduce the likelihood of damage to theskin tissue during removal. The retention member 340 can be removed fromthe retainer body 110, for example, by applying a lifting force 147 toregions 143 a-b to overcome the engagement between the apertures 141 and149 and the locking posts 151 and 159, as illustrated in FIG. 6E. Atthis stage, the retainer body 110 and the retention member 140 are twodistinctly separate pieces, and the retention member 140 can bediscarded.

As shown in FIGS. 6F-H, the retainer body 110 can be decoupled from theanchors 120 a-b while the anchors 120 a-b remain engaged with the skin30. In one embodiment, the stop member 136 of the actuator 130 can beadjusted to permit the release of the retainer body 110. For example, asshown in FIG. 6F, the actuator wings 137 a-b can be adjusted todisengage the retainer body 110 so that the actuator 130 can slidethrough the channel 111. As shown in FIG. 6G the retainer body 110 canbe moved away from the skin penetration point 32 upon application of aremoval force 117 on the retainer body 110. The removal force 117 maycause the retainer body 110 to slide longitudinally away from theanchors 120 a-b until the retainer body 110 decouples from the actuator130 and the anchors 120 a-b (refer to FIG. 6H).

Referring now to FIG. 6I, the anchors 120 a-b can be removed from theskin penetration point 32 in a manner that reduces the likelihood ofdamage to the surround skin tissue. As previously described, the anchors120 a-b may be separated and individually maneuvered so that one anchor120 b can be removed independent of the other anchor 120 a. In thisembodiment, the anchors 120 a-b may be separated from one another afterthe retainer body 110 is removed and the body portions 131 a-b can beseparately manipulated by a user. The anchors 120 a-b can be separatedfrom each other by, for example, applying a separation force 127 to thesecond anchor 120 b, which urges the second anchors 120 b apart from thefirst anchor 120 a. Thereafter, the anchors 120 b can be separately andindividually removed from the skin penetration point 32 by shifting theanchor 120 b in a direction that favors release of the tine 129 b fromthe subcutaneous layer 34. Similar movements can be repeated for theremaining anchor 120 a so to completely remove the anchors 120 a-b in amanner that reduces the likelihood of damage to the surround skintissue.

It should be understood that, in some embodiments, the anchor device isnot limited to the previously described configurations. For example, inparticular embodiments, the deployment of an anchor system can be aidedthrough the use of a delivery device (refer to FIGS. 10A-B). Also, theanchors can be released from the retainer body (e.g., to facilitateremoval of the anchors) using other implementations (refer, for example,to FIG. 9).

Referring now to FIGS. 7-9, some embodiments of an anchor system 700 mayinclude an anchor device 701 that removably couples with a deliverydevice 750 to facilitate advancement of the anchors 703 toward a skinpenetration point. As described in more detail below, the deliverydevice 750 can be configured to be readily grasped and manipulated by auser so as to firmly position the anchor device 701 proximate to theskin penetration point during deployment of the anchors 703 through theskin and into the subcutaneous region. Moreover, as described in moredetail below, the anchor device 701 may include a release member 704that facilitates prompt separation of the anchors 703 away from theretainer body 702, thereby permitting each anchors 703 to be removedfrom the skin penetration point independently of the other anchor(s) ina manner that reduces the likelihood of damage to the tissue surroundingthe skin penetration point. As with previously described embodiments,the anchors 703 can be configured to be deployed into the subcutaneouslayer of a patient's skin to secure a medical device (e.g., a catheteror the like) in place relative to a skin penetration point. For example,as shown in FIG. 8, the anchors 703 a-b include anchor tines 728 a-bthat have a curved shape to abut the underside of the skin layer. Thetines 728 a-b can extend to free ends having atraumatic bulbs 729 a-bthat are configured to substantially reduce the likelihood of damage tothe skin when the anchors 703 a-b are deployed and withdrawn through theskin penetration point.

In this embodiment, the retainer body 701 includes locking pillars 705a-b that mate with apertures 727 a-b on a retention member 725. Similarto previously described embodiments, the retention member 725 includes achannel 726 to secure a medical device (e.g., a catheter 20 as shown inFIGS. 10A-G) to the retention member 725. Furthermore, the lockingpillars 705 a-b can mate with a cap member 730 to compress the retentionmember 725 between the retainer body 702 and the cap member 730. Theretention member 725 may comprise silicone or another flexible materialso that the channel 726 can flexibly adjust to receive the catheter oranother medical instrument therein. Accordingly, the apertures 727 a-bcan be forced over the corresponding pillars 705 a-b, and thereafter theuser may press the catheter 20 (FIG. 10C) into the channel 726. As thecap member 230 engages the pillars 705 a-b, the compression of theretention member 725 causes the wall of the channel 726 to apply africtional engagement to the outer surface of the catheter 20. Owing tothe flexible nature of the retention member 725, the locking apertures727 a-b can stretch to fit over the locking pillars 705 a-b during themating process. The cap member 730 may comprise a more rigid material,such as ABS or the like, so as to apply the compressive force to theretention member 725. In such circumstances, the cap member 730 caninclude apertures 731 a-b having notches, detents, or other structuresthat mate with corresponding structures on the locking pillars 705 a-bso that the cap member 730 remains coupled to the retainer body 702.

Still referring to FIGS. 7-9, the retainer body 702 can include a guidechannel 706 that provides guidance for the anchor device 701 duringadvancement toward the skin penetration point. For example, the guidechannel 706 can be guided by the outer surface of the catheter 20 whilethe anchor device 701 is advanced toward the skin penetration point 32.The guide channel 706 can define a mouth that is delivered proximate tothe skin penetration point, and thereafter the anchors 703 can bedeployed to extend distally from the retainer body 701 and through theskin penetration point.

In some embodiments, the retainer body 701 can include a release member704 that can be adjusted to cause the anchors 703 to decouple from theretainer body 702. Referring to FIG. 9, in this embodiment, the releasemember 704 can include a slidable body 709 releasably coupled to theretainer body 701. For example, the slidable body 709 movably engages ananchor channel 713 so that the release member can slide longitudinallyaway from the retainer body 702. The anchor channel 713 can be shapedsuch that a portion of its perimeter substantially matches a portion ofthe anchors 703 a-b when they are conjoined. For example, a portion ofeach of the anchors 703 a-b includes anchor handles 714 a-b that can fitwithin a tapered portion 712 of the anchor channel 713. The anchors 703a-b can be arranged between the retainer body 702 and the release member704 so as to shift from a non-deployed position (FIG. 10A) to a deployedposition (refer to FIG. 10B). When in the non-deployed position, theanchors 703 a-b are substantially contained between the anchor channel713 and the slidably body 709 so that the tines 728 a-b are at leastpartially flexed within the tapered portion 712. As described in moredetail below, the anchors 703 a-b can be forced to the deployed positionin which the anchors 703 a-b are shifted longitudinally out of theanchor channel 713 to extend distally from the retainer body 702.Similar to previously described embodiments, the anchors 703 a-b maycomprise a material that exhibits superelasticity when used in apatient's body.

As shown in FIG. 9, the slidable body 709 can includes a tapered tip 710that facilitates assembly of the release member 704 with the retainerbody. For example, the tapered tip 710 can be inserted into a proximalopening of the anchor channel 713 so that the slidably body 709 mateswith guide rails in the anchor channel 713. When the release member 704is fully mated with the retainer body 701, the tapered end 710 of theslidable body 709 mates with the tapered portion 712 of the channel 713.In some embodiments, the release member 704 can be releasably lockedinto position when it is fully mated with the retainer body 701, forexample, through the use of a snap-fit connection or the like. Therelease member 704 can include one or more surface structures 711 thatare configured to mate with the anchor handles 714 a-b when the anchorsare in the non-deployed position, the deployed position, or both. Forexample, the surface structures 711 may include one or more guide railsthat permit the anchor handles 714 a-b to shift distally inside theanchor channel 713 (e.g., from the non-deployed position to the deployedposition) upon application of an actuator force, and the guide rails maythereafter inhibit movement of the anchor handles 714 a-b in a reversedirection (e.g., thereby preventing accidental withdrawal of the anchors703 a-b after deployment).

Referring again to FIGS. 7-9, the release member 704 can include agripping member 721 that facilitates separation of the sled slidablybody 709 from the retainer body 702. In this embodiment, the grippingmember 721 is in the form of a pull-ring that can be handle by a user'sfinger. In some implementations, a user can grasp the gripping member721 and exert a longitudinal force in a proximal direction to overcomethe snap-fit engagement and thereby free the release member 704 from theretainer body 702. As in more detail described below, when the releasemember 704 slides out of the retainer body 702 such that they becomecompletely decoupled, the anchors 703 a-b are free to fall out of theanchor channel 713 and thereby separate from the retainer body 702. Itshould be understood from the description herein that, in someembodiments, the anchor channel 713 can include stops that inhibit theanchors 703 from movement in the proximal direction when the releasemember 704 is being pulled from the retainer body 702. Thus, the anchors703 a-b can remain in the deployed configuration while the releasemember 704 is being pulled from the retainer body 702.

Referring to FIG. 7, some embodiments of the anchor system 700 caninclude the delivery device 750 that facilitates delivery and deploymentof the anchor device 701. In this embodiment, the delivery device 750includes a body 751 that can be formed of a rigid material andergonomically shaped to allow a user to comfortably articulate the body751 to skillfully deploy an anchor device. The body 751 includes acavity 752 into which the anchor device 701 (e.g., the retainer body702, retention member 725, and (optionally) cap 730) can be inserted andreleasably coupled. In this embodiment, the cavity is configured toreceive the retainer body 702 and the retention member 725, while thecap member 730 is employed after the retainer body 702 is separated fromthe delivery device 750. The anchor device 701 can couple into thecavity 752 with a snap-fit engagement, thereby allowing the anchordevice 701 to be partially contained housed within the delivery device750 until it is deployed. In some embodiments, the anchor device 790 canbe retained in the cavity 752 through use of a locking mechanism such asa tab or detent that extends from the retainer body 701 and mates with acorresponding recess within the cavity 752 (not shown in FIG. 7). Insome embodiments, the anchor device 701 can be housed completely withinthe cavity 752; in other embodiments, only a portion of the anchordevice 701 is housed within the cavity 752.

The delivery device 750 can include a deployment piston 753 that actsupon a portion of the anchor device 701 when force is applied thereto.In the embodiment depicted in FIG. 7, the deployment piston 753 is inthe form of a plunger (e.g., a syringe-like plunger) that can beforwardly advanced (e.g., under force from a user's thumb) to exert adeployment force on a portion of the anchor device 701. For example, atongue 754 can be coupled to a distal portion of the deployment piston753 to extend into the anchor channel 713 (FIG. 9) and act upon theanchors 703 therein. As described in more detail below, the tongue 754can push upon the anchor handles 714 a-b (FIG. 9) to force the anchorsfrom the non-deployed position to the deployed position. Such an actioncan occur when the user forces the deployment piston 753 from an initialposition to an intermediate position relative to the delivery devicebody 751.

Still referring to FIG. 7, in some embodiments, the deployment piston753 may also serve to separate the anchor device 701 and the deliverydevice 750 after deployment of the anchors 703. For example, in theembodiment depicted in FIG. 7, the deployment piston 753 can include apusher bar 755 to abut against the anchor device 701 (e.g., abutsagainst a rearward surface of the retainer body 702 or the retentionmember 725). As described in more detail below, the pusher bar 755 canforce the anchor device 701 to separate from the cavity 752 of thedelivery device 750 after the anchors 703 are deployed in thesubcutaneous region. This separation action can occur when the userforces the deployment piston 753 from the intermediate position to afinal distal position relative to the delivery device body 751.

In this embodiment, the tongue 754 and the pusher bar 755 are fixedlycoupled to the deployment piston 753. The tongue 754 extends further inthe distal direction than the pusher bar 755. As such, the tongue 754can act to initiate deployment of the anchors 703 before the pusher bar755 forces the anchor device to fully separate from the cavity 752. Inother embodiments, the tongue 754 and the extension member 755 can beindependently extendable. In such embodiments, the deployment piston 753may have first and second piston surfaces (not shown in FIGS. 7-9) thatindependently engage the tongue 754 and the pusher bar 755 when thedeployment piston 753 is forwardly advanced. Such an arrangement may berealized by allowing a portion of the deployment piston 753, includingthe first piston surface, to slide underneath, or proximal to the pusherbar 755 as the tongue 754 is being deployed.

Still referring to FIG. 7, some embodiments of the delivery device 750includes a deployment gauge 766 that indicates a position of thedeployment piston 753. In the embodiment of FIG. 7, the deployment gauge766 has markings that visually indicates to the user the position of thedeployment piston 753 (e.g., the initial position, the intermediateposition, and the final distal position). Thus, the deployment gauge 766can be used to determine the distance that the piston 753 should beadvanced to deploy the anchors 703 and to detach the anchor system 701from the delivery device. In some embodiments, marking indicia can beplaced on the deployment piston 753 and the deployment gauge 766 is awindow with marking indicia that allows a user to visually determine howfar the deployment piston 753 has traveled in a longitudinal direction.In addition or in the alternative, the deployment gauge 766 may have anindicator in the form of an audible or tactile “click” for one or moreof the initial position, the intermediate position, or the final distalposition.

Referring now to FIGS. 10A-10G some embodiments of the anchor system 700can be implemented to secure a medical instrument at a selected locationon a patient's body. For example, the anchor device 701 can be used incertain processes to secure the catheter 20 in a selected positionrelative to the skin penetration point 32 that is occupied by thecatheter 20. Similar to the embodiments previously described herein, theanchor device 701 may properly secure the catheter 20 in this operativeposition without necessarily requiring sutures or adhesive tapes bondedto the skin.

As shown in FIG. 10A, a medical instrument (in this particular example,a catheter 20) has been delivered through a patient's skin 30, throughthe subcutaneous layer 34, and into a targeted vein 40. After thecatheter 20 is advanced through the skin, the anchor device 701 can bedirected along the catheter 20 and toward the skin penetration point 32that is occupied by the catheter. As previously described, the skinpenetration point 32 can be formed, for example, by an incision in theskin 30. In this embodiment, the anchor device 701 is advanced along theouter surface of the catheter 20 by handling the delivery device 750.The delivery device 750 can be configured so that a user can readilydirect the anchor device 701 on a path toward the skin entry point 32.During such delivery, the guide channel 706 of the retainer body 702 canbe guided along the outer surface of the catheter 20 until it isarranged proximate to the skin penetration point 32. When the deliverydevice 750 is used to direct the anchor device 701 to such a position,the user can prepare to shift the anchors 703 away from the non-deployedconfiguration. In this embodiment, the anchors 703 are substantiallyenclosed by the retainer body 702 (and the release member 704 (not shownin FIG. 10A) when in the non-deployed configuration.

Referring to FIG. 10B, the user can deploy the anchors 703 a-b byapplying a deployment force 756 to the piston 753 of the delivery device750. Such force 756 can be translated through the tongue 754 (FIG. 7) tothe anchors 703 a-b so that the anchors 703 a-b move from thenon-deployed configuration to the deployed configuration. The indicator766 of the delivery device can show that the piston is actuated from theinitial position to an intermediate position (to cause the anchors 703a-b to deploy). Because the delivery device 750 in this embodiment canbe readily manipulated by the user during deployment, the user canmaintain the position of the guide channel 706 while the anchors 703 a-bare moved. As such, the delivery device 750 facilitates properpositioning of the anchor device 701 (e.g., in a position adjacent tothe skin penetration point 32) while the anchors 703 a-b are deployed.The anchors 703 a-b can be fully deployed through the skin penetrationpoint 32 and into the subcutaneous layer 34. When the anchors 703 a-breach the subcutaneous layer 34, the anchor tines 728 a-b can flexoutward to the deployed configuration. Accordingly, the tines 728 a-bcan secure the anchor device 701 in a selected position relative to theskin penetration point 32.

Referring to FIG. 10C, the anchor device 701 can be decoupled from thedelivery device 750 by applying a detachment force 757 to the deploymentpiston 753. This force 757 can be translated through the pusher bar 755(FIG. 7) to the anchor device 701 so that the anchor device 701 isdislodged from the cavity 752 of the delivery device 750. The indicator766 of the delivery device may show that the piston is actuated from theintermediate position to the fully distal position (to cause separationfrom the anchor device 701). After the delivery device 701 is separatedfrom the anchor device 701, the delivery device 750 can be discarded(e.g., thrown away in a trash bin, a recycle bin, or another discardbin). The catheter 20 can be pressed (e.g., with the user's fingers oranother instrument) to fit into the full length of the channel 726 inthe retention member 725, thereby coupling the catheter 20 to the anchordevice 701. If the catheter was delivered to the targeted internaltissue site prior to deployment of the anchor device 701, then thecatheter can be promptly inserted into the channel 726. If, however, thecatheter 20 requires further adjustment after the anchor device 701 isdeployed, then the catheter 20 can be further inserted (or retracted) tothe targeted tissue site before the catheter 20 is fit into the channel726. After the catheter 20 is engaged inside the channel 726 of theretention member 725, the cap member 730 can be pressed onto the lockingpillars 705 a-b to compress the retention member 725 around the catheter20 (e.g., to create a frictional holding force).

As shown in FIG. 10D, the anchor device 701 is assembled to secure thecatheter 20 in a selected position relative to the skin penetrationpoint 32. Thus, after the catheter 20 is delivered into the targetedvein 40 (or other bodily lumen) and after the anchors 703 a-b aredeployed in the subcutaneous region 34, the cap member 730 can mate withthe retainer body 702 so that the retention member 725 lockingly engagesthe catheter 20 to secure its position relative to the retainer body701. In this embodiment, the retention portion 725 can secure thecatheter 20 relative to the skin penetration point 32 throughout themedical procedure in which in the catheter 20 in employed. Theconfiguration illustrated in FIG. 10D shows the anchor device 701 as itmay be used to secure a patient's catheter 20 over a period of time, forexample, for hours, one to seven days, or longer. As previouslydescribed, the anchors 703 a-b may be designed such that the tines 728a-b include a curvature that abuts against the underside of the skin 30in a manner that reduces the likelihood of the tines 728 a-b puncturingthrough the underside of the skin 30. When the tines 728 a-b aredeployed in the subcutaneous region 34, the anchor device 701 can besecured to the patient without necessarily requiring sutures or adhesivetapes to bond the retainer body 702 to the skin 30.

Referring to FIGS. 10E-G the catheter 20 may be withdrawn from thepatient (e.g., after the procedure) while the anchors 703 a-b remain inthe subcutaneous region 34. As such, in some embodiments, the anchors703 a-b can collectively penetrate into the subcutaneous layer 34 aspart of the assembled device 701 9 refer to FIG. 10B), but may beseparately and individually withdrawn from the penetration point 32during the removal process (refer to FIG. 10G).

In the embodiment depicted in FIG. 10E, at least a portion of the anchordevice 701 may be retracted with the catheter 20 when the catheter 20 isto be removed from the skin 30. For example, the release member 704 canbe actuated to separate the anchors 703 a-b from the retainer body 702,thereby permitting the retainer body 702, the retention member 725, andthe cap member 730 to be withdrawn along with the catheter 20. Aspreviously described, the release member 704 may include the slidablebody 709 that can be pulled out of the anchor channel 713 (FIG. 9). Forexample, the user may apply a release force 729 to the ring 721, whichcauses the slidably body 709 to move in a proximal direction away fromthe retainer body 702. The surface structures 711 of the release member704 can at least partially define a chamber 718 in which the anchorhandles 714 a-b (FIG. 9) reside. For example, when the anchors 703 a-bare forced from the non-deployed configuration to the deployedconfiguration, the anchor handles 714 a-b may shift from a position in anarrowed region of the chamber 718 to a position where the chamberwidens (along the tapered tip 710). Accordingly, chamber 718 can beconfigured so that the release member 704 may be pulled rearwardly inthe proximal direction without causing the anchors 703 a-b to alsowithdraw in the proximal direction.

As shown in FIG. 10F, after the release member 704 is separated from theretainer body 702, the retainer body 702 (and the catheter 20 engagedtherewith) can be withdrawn away from the anchors 703 a-b. In thisembodiment, the retainer body 702 can be lifted (refer to separationforce 717) away from the anchors 703 a-b—so that the anchor handles 714a-b are removed from the anchor channel 713 (FIG. 9). In suchcircumstances, the retainer body 702 and the retention member 725 canremain engaged with the catheter 20 during removal of the catheter fromthe skin penetration point 32. The anchors 703 a-b can remain engagedwith the skin 30 during the removal of the catheter 20. The catheter 20can be fully retracted from the skin by application of a catheterwithdrawal force 27. Because the retainer body 702 and the retentionmember 725 remain engaged with the catheter 20, these components canalso be retracted away from the skin penetration point 32 and thendiscard along with the catheter 20.

As shown in FIG. 10G after the anchors 703 a-b are free from theretainer body 702, they can be individually maneuvered in such a way asto reduce the likelihood of damage to the skin tissue during removal.Similar to previously described embodiments, the anchors 703 a-b may beseparated and individually maneuvered so that one anchor 703 a can beremoved independent of the other anchor 703 b. The anchors 703 a-b canbe separated from each other by, for example, applying a separationforce 707 to the first anchor 703 a, which urges the first anchor 703 aapart from the second anchor 703 b. Thereafter, the anchors 703 a-b canbe separately and individually removed from the skin penetration point32 by shifting the anchor 703 a in a direction that favors release ofthe tine 728 a from the subcutaneous layer 34. Similar movements can berepeated for the remaining anchor 703 b so to completely remove theanchors 703 a-b in a manner that reduces the likelihood of damage to thesurround skin tissue.

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the disclosed embodiments. For example, theanchor devices described herein can be configured to secure cathetersthat enter into bodily structures other than a vein 40. For example, thecatheter 20 may be configured to pass into arteries, bodily lumens, andother cavities. In another example, the anchor device described hereincan be configured to mate with medical instruments other than a catheter20, such as endoscopes, illumination instruments, retractioninstruments, or the like. Accordingly, other embodiments are within thescope of the following claims.

What is claimed is:
 1. An anchor system for securing a medicalinstrument, comprising: a retainer body to couple to a catheter; aplurality of flexible anchors releasably coupled to the retainer body,each anchor comprising a flexible tine that is deployable in asubcutaneous region to secure the retainer body relative to apenetration point; and an actuator that, when activated, moves theanchors from a non-deployed position to a deployed position in which theanchors flexible anchors extend distally from the retainer body and intothe subcutaneous region.